Analyzing changes in oral microbiome during dental implant placement

Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement

This study looks at how the bacteria in the mouth change when people with severe gum disease get dental implants and whether different implant materials affect these changes.

Quick facts

• Study type: Observational
• Enrollment: 12 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Case Western Reserve University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06149585 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the changes in the oral microbiome that occur when patients transition from having some teeth to being fully edentulous, as well as after the placement of dental implants. It focuses on individuals with severe periodontitis and evaluates how different implant materials and surfaces may influence microbial colonization. The study will also assess the variability of these changes to inform future longitudinal studies. By understanding these dynamics, the research seeks to improve outcomes for patients undergoing dental implant procedures.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 21 and older who have been diagnosed with Stage III or IV periodontitis and are scheduled for full mouth extraction and dental implant placement.

Not a fit: Patients with conditions requiring chronic antibiotic use, prolonged steroid use, or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for preventing complications associated with dental implants in patients with a history of periodontitis.

How similar studies have performed: Previous studies have shown significant findings regarding microbial changes in relation to dental implants, but this specific approach focusing on edentulous patients with periodontitis is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. At least 21 years of age
2. Diagnosis of Stage III or IV periodontitis based on full mouth probing and full mouth x-rays
3. Planned for full mouth extraction and replacement by dental implants.
4. Rehabilitation with Implant supported restorations either maxilla and/ or mandible.
5. At least 2 implants available for examination.
6. No bone augmentation required.

Exclusion Criteria:

1. Conditions requiring chronic routine prophylactic use of antibiotics.
2. Conditions requiring prolonged use of steroids.
3. History of leukocyte dysfunction and deficiencies
4. Bleeding disorders
5. History of neoplastic disease requiring use of radiation or chemotherapy
6. Metabolic bone disorders
7. Uncontrolled endocrine disorder
8. Use of any investigational drug or device within the 30 day period prior to implant surgery.

10\. Alcoholism or drug abuse 11. Patient infected with HIV 12. Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability.

Local Exclusion Criteria

1. Local inflammation
2. Mucosal disease such as erosive lichen planus
3. History of local irradiation therapy
4. Osseous lesion.
5. Active infection with suppuration or fistula track.
6. Persistent intraoral infection different than periodontitis

Where this trial is running

Cleveland, Ohio

• Case Western Reserve University Department of Periodontics — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Gian Pietro Schincaglia, DDS,PhD — Case Western Reserve University
• Study coordinator: Gian Pietro Schincaglia, DDS,PhD

Conditions Edentulous Mouth; Periodontal Diseases; Periodontitis, Adult; Microbial Colonization